enriched honey with soluble fiber and polyphenols on satiety and dyslipidemia

Conditions: Overweight and Obesity; Dyslipidemias

Summary: the aim of this trial is to evaluate the possible benefits on saciety and dyslipidemia in subjects with overweight/obesity (bmi ≥25 y \<40 kg / m2) and dyslipemia after consumption of a modifed honey with soluble fiber and polyphenols. some studies have shown the contribution of high-fiber foods in the reduction of the cardiovascular risk. besides, polyphenols have reported with their potent antioxidant effect and their implication lowering the vardiovascular risk.

the trial was designed as a randomized, parallel, double-blind and controlled study with 2 experimental arms. this study was performed to evaluate the effect on saciety and dyslipidemia of subjects with overweight/obesity after a long consumption (3 months) of a modified honey with soluble fiber and polyphenols. additionally, a short-term randomized, cross-over, doble-blind and controlled trial was also performed to evaluate immediate saciety effect on the same subjects. for the middle-term study, investigators included 67 participants (8 men and 59 women) between 18 and 65 years (bmi ≥25 and \<40 kg / m2). all volunteers were randomized into 2 study groups, and participants received the 2 different study products during the 3 months. on the other hand, the associated short-term trial included 10 participants (5 men and 5 women) between 18 and 65 years (bmi ≥25 and \<40 kg / m2). all volunteers were randomized into 2 study groups, and participants took the 2 different study products in two non-consecutive days.

Eligibility criteria:
inclusion criteria: * men and women from 18 to 65 years old. * body mass index (bmi) ≥25 and \<40 kg/m2. * cardiovascular risk \<10% to 10 years measured by regicor. * total cholesterol ≥ 200 mg/d and at least 2 factors included in the following list: * ≥ 45 years or women ≥ 55 years. * family history of cardiovascular disease (cvd) in first degree male relative less than 55 years of age and less than 65 years in women. * hdl cholesterol: men \<40 or women \<50. * triglycerides ≥ 150mg/dl and \<200 mg/dl * ldl cholesterol ≥ 130mg/dl and \< 160mg/dl * smoker * willingness to follow a healthy and balanced hypocaloric diet with mandatory physical activity * social or familiar environment that prevents from accomplishing the dietary treatment * adequate cultural level and understanding for the clinical trial. * signed informed consent exclusion criteria: * body mass index (bmi) \<25 and ≥40 kg/m2. * individuals diagnosed with diabetes mellitus type 1 or 2. * individuals with dyslipidemia on pharmacological treatment. * individuals with hypertension on pharmacological treatment. * individuals diagnosed with eating disorders. * individuals fructose-intolerant. * individuals with a diagnosis of celiac disease or a gluten intolerance. * individuals with severe chronic diseases (hepatic, kidney, ...) * individuals receiving a pharmacological treatment that modifies the lipid or glucose profile. * individuals who have participated in the last 3 months in a program or clinical trial to lose weight. * individuals with mental illness. * smokers wanting to stop to smoke during the period that clinical trial lasts. * individuals with high alcohol consumption (\> 2-3 servings/ day in men and\> 1 serving/day in women (1 serving = 1 glass of wine or 1 bottle of beer). * individuals with large weight fluctuations of more than 4 kg or who have undergone in six months a weight loss diet. * individuals with sensory problems. * individuals with gastrointestinal diseases that affect the digestion or absorption of nutrients. * individuals under pharmacological treatment for losing weight unless treatment is suspended 30 days before the start of the trial. * subjects with intense physical activity. * subjects with food allergies to meals included in breakfast, study product or lunch or that reject their consumption * pregnant or breastfeeding women.

Keywords: saciety honey fiber polyphenols visual analogue scale cross-over parallel